Sample dots were provided for each lot on attached spreadsheet.A sample from each lot provided was tested with a 3m lead check to confirm these dots were manufactured with lead-based ink.In addition, a 130 dots were subjected to a standard sterilization process of 270ºf for 4 minute cycle and a 20 minute dry time.Completion of testing yielded a 100% success rate in the dots transitioning to their signal color as intended.Dots were then subject to a 7 day light study in which they were exposed to both artificial and natural light sources for 24 hours over a day period.The results showed some fading of the dots, but not reversion back to the initial color blue.Crosstex could not replicate the reversion of the dots back to blue.It is important to note that despite the occurrence of fading after sterilization, this product operates as intended.The sterilization dots are used as proof of exposure to steam not sterility.Note: a retrospective review of potential serious injury complaints was performed.This mdr was identified as a reportable malfunction as a result and filed as part of the review activities.
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